FDA: Class I recall of Medtronic implantable drug infusion pumps

Editor's Note

The Food and Drug Administration (FDA) on March 14 categorized the recall by Medtronic (Minneapolis) of its SynchroMed II and SynchroMed EL implantable drug infusion pumps as Class I, the most serious.

The pumps are being recalled because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large doses of medication to the patient’s spine. This can result in a drug overdose or under dose, which can lead to serious adverse consequences such as respiratory depression, coma, or death.

The recalled pumps were manufactured between September 2013 and October 2016.